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Treatment of Severe Heart Failure by Ultrafiltration

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ClinicalTrials.gov Identifier: NCT00360958
Recruitment Status : Completed
First Posted : August 7, 2006
Last Update Posted : January 28, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Patients with severe congestive heart failure show increased fluid body content which is often resistant to conventional diuretic therapy. Therefore, chronic heart failure patients have frequent access to the emergency room and hospital for hemodynamic instability. Ultrafiltration is a simple renal replacement therapy which reduces fluid overload. The purpose of this study is to determine whether periodic ultrafiltration sessions maintain patients in stable clinical condition and reduce hospitalisations as well as access to emergency heart failure treatment.

Condition or disease Intervention/treatment Phase
Severe Congestive Heart Failure Procedure: ultrafiltration Phase 4

Detailed Description:
Patients with severe heart failure (New York Heart Association [NYHA] III-IV) and fluid overload will be randomized to ultrafiltration (UF group) or conventional medical treatment (Control group). Patients follow-up at least monthly visit for one year. Ultrafiltration will be repeated during follow-up in case of body weight gain due to fluid accumulation. Ultrafiltration will be performed during short term hospitalization.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ultrafiltration for the Chronic Treatment of Severe Congestive Heart Failure
Study Start Date : August 2006
Primary Completion Date : October 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Ultrafiltration
Ultrafiltration treatment
Procedure: ultrafiltration
Active Comparator: Usual treatment
Usual HF treatment
Procedure: ultrafiltration


Outcome Measures

Primary Outcome Measures :
  1. number of hospitalizations for heart failure [ Time Frame: End of study ]

Secondary Outcome Measures :
  1. long term major adverse clinical events including death [ Time Frame: End of study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Severe heart failure (NYHA III-IV) with fluid overload
  • Ejection fraction < 40%
  • Estimated fluid overload > 4 kg

Exclusion Criteria:

  • Severe renal insufficiency
  • Acute pulmonary edema and/or cardiogenic shock
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00360958


Locations
Italy
Centro Cardiologico Monzino
Milan, Italy, 20138
Sponsors and Collaborators
Centro Cardiologico Monzino
Investigators
Principal Investigator: Piergiuseppe Agostoni, MD.PhD Centro Cardiologico Monzino
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Piergiuseppe Agostoni, MD PhD, Centro Cardiologico Monzino
ClinicalTrials.gov Identifier: NCT00360958     History of Changes
Other Study ID Numbers: CCM S67/306
First Posted: August 7, 2006    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2016

Keywords provided by Piergiuseppe Agostoni, Centro Cardiologico Monzino:
ultrafiltration
heart failure
fluid overload

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases